Laboratory Proficiency Testing Market Size, Share & Trends Analysis Report By Industry Scope (Clinical Diagnostics, Pharmaceuticals), By Technology (Cell Culture, PCR), By End Use, By Region, And Segment Forecasts, 2020 - 2027

Report Overview

The global laboratory proficiency testing market size was valued at USD 1.1 billion in 2019 and is expected to expand at a compound annual growth rate (CAGR) of 7.3% from 2020 to 2027. The growth can be attributed to the increasing adoption of laboratory proficiency testing owing to stringent regulations as well as increasing focus on diagnostic laboratories due to the COVID-19 pandemic. The rising number of new proficiency testing programs being launched by key players is also expected to drive the market. Proficiency testing helps ensure that the tests for the detection of the novel coronavirus are being interpreted correctly, processed, and administered appropriately to obtain high accuracy and confidence in results. Thus, proficiency tests provide laboratories with the assurance that their diagnosis is carried out accurately.

Proficiency testing is crucial in all regions affected by the pandemic. Various organizations are undertaking initiatives to combat the challenges faced by laboratories related to accreditation, thereby boosting the market growth. For instance, in November 2020, the WHO and the European Civil Protection and Humanitarian Aid Operations (ECHO) worked with the Department of Health (DOH) and local governments to provide training and ensure the establishment and accreditation of testing laboratories.

The increasing outbreak of foodborne illness due to the consumption of unsafe foods that contain viruses, bacteria, chemical substances, and parasites is anticipated to accelerate market growth. According to the WHO, it is projected that approximately 600 million people or around 1 in 10 people globally suffer from illnesses due to eating contaminated food, leading to 420,000 deaths every year. The presence of food contaminants can cause more than 200 diseases, including diarrhea and cancer.

The legalization of cannabis products in the U.S. in December 2018 and the gradual expansion of this market are propelling the need for the testing of safety and efficacy for medical use. Increasing demand for high-potency cannabis has resulted in the formation of laboratories that provide assays to specifically measure cannabis potency. Therefore, the implementation of regulations to test potency and contaminants is expected to boost market growth.

Industry Scope Insights

The clinical diagnostics segment accounted for the largest revenue share of 34.5% in 2019. This is attributed to the development of complex diagnostic tests and the high rate of early diagnosis being conducted, which makes quality management with the use of proficiency testing an essential aspect in clinical diagnostics. Furthermore, proficiency testing can improve the efficiency, test reproducibility, and testing accuracy of clinical diagnostics.

The clinical diagnostics segment is subdivided into clinical chemistry, immunochemistry, hematology, oncology, molecular diagnostics, and coagulation. The immunochemistry held a substantial market share in 2019 owing to the presence of tests for allergies, autoimmune diseases, hormones, infectious diseases, urine electrophoresis, serum electrophoresis, and immunoglobulin in the segment.

In the pharmaceutical industry, laboratories conducting quality checks play a crucial role in the quality control of products that are going to be released in the market. Thus, these laboratories need to continuously assess themselves. LGC offers the PHARMASSURE program to help meet the specialized demands in the pharma industry. It includes all the necessary tests, such as chemical, microbiology, sterility, and endotoxin.

End-use Insights

Hospitals held the largest share of 32.8% in 2019. The diagnostic laboratories segment is expected to witness the fastest growth over the forecast period owing to the wide usage by patients, hospitals, and physicians. This segment is further divided into independent and specialty laboratories. Diagnostic labs have to compete with hospital laboratories for specimens. However, the wide range of tests provided by these labs in a limited time is a competitive advantage.

Pharmaceutical and biotechnology companies are major hubs for production and R&D. Companies need to maintain sterility and quality standards for raw materials, production, and finished products. The proficiency testing services in the pharmaceutical and biotechnology companies can ensure testing accuracy and validate laboratory efficacy. This also allows the companies to modify and correct any processes that are not as per regulatory guidelines or functioning properly, thus maintaining the quality of the final product for FDA approval.

Contract research organizations are expected to witness significant growth over the forecast period. Emerging economies including India and China are the major hub for CROs. Stringent FDA guidelines regarding R&D and clinical trials are expected to expand the scope of laboratory proficiency testing through CROs.

Technology Insights

The cell culture segment accounted for the largest revenue share of 30.4% in 2019. It is anticipated to grow at a lucrative rate in upcoming years owing to its use in diagnosing the presence of infectious microorganisms in the blood. These tests are also conducted in the pharmaceutical industry to check for the benefits of vaccines and cell culture-based products. The rise in the adoption of cell-culture-based products, such as monoclonal antibodies, has led to an increase in the adoption of cell culture tests to achieve maximum production from microbial strain cultures. The available proficiency tests in this segment are to measure the efficacy of laboratories and check for contaminants and impurities in cell cultures.

The immunoassays segment held a substantial market share in 2019 owing to its use in the diagnosis of specific antigens or antibodies in the blood. They are accurate and quick to use and can be used in labs as well as on-site. They are also used for the quantification of any specific analytes in the blood with the use of immunological reactions.

Chromatography offers advantages such as reliability and safety. For instance, Merck offers an extensive gas chromatography proficiency testing material to ensure the efficacy of the device and reliability of the results at prices as low as USD 257. HPLC is also provided in the PHARMASSURE scheme of LGC to meet the specialized demands of the pharmaceutical industry.

Regional Insights

North America accounted for the largest revenue share of 44.2% in 2019 and is expected to maintain its lead over the forecast period. This is attributed to the stringent regulatory framework and the growing adoption of proficiency testing. Moreover, the presence of major players in the U.S. is expected to contribute to the growth of the regional market.

Asia Pacific is anticipated to exhibit the fastest CAGR of 9.5% during the forecast period. Increasing healthcare awareness and the rising number of laboratories going for international accreditations in the region are anticipated to fuel the market growth. 

Key Companies & Market Share Insights

The market for laboratory proficiency testing operates with high complexity. It involves quarterly and annual schemes that allow testing competence of laboratories and has products to test the proficiency of labs.

The demand for proficiency testing has seen a surge during the SARS-CoV-2 pandemic owing to the adoption of new technologies by laboratories to process samples. Governments have also played a crucial role in ensuring proficiency testing to get better statistics related to the pandemic. Thus, the market is expected to see a spike in demand.

Companies are engaging in partnerships and mergers & acquisitions aiming to strengthen their product portfolio, manufacturing capacities, and provide competitive differentiation. For instance, in October 2020, the Central Testing Laboratory of the Abu Dhabi Quality & Conformity Council implemented a proficiency testing program in collaboration with Biogenix Lab to verify the competency of medical laboratories carrying out COVID-19 tests.

The presence of prominent players in this market space significantly diminishes the opportunities for a new entry into the market as it is difficult to match the high capital requirements. Some prominent players in the global laboratory proficiency testing market include:

• LGC Limited

• American Proficiency Institute

• College of American Pathologists

• Bio-Rad Laboratories, Inc.

• Randox Laboratories Ltd.

• QACS - The Challenge Test Laboratory

• Merck & Co., Inc.

• Weqas

• ERA

• AOAC International

• BIPEA

• NSI Lab Solutions

• Absolute Standards, Inc.

• RCPA

• UK NEQAS

• INSTAND

Laboratory Proficiency Testing Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the global laboratory proficiency testing market report on the basis of industry scope, technology, end-use, and region:

• Industry Scope Outlook (Revenue, USD Million, 2016 - 2027)

  • Clinical Diagnostics

  • Clinical Chemistry

  • Immunochemistry

  • Hematology

  • Oncology

  • Molecular Diagnostics

  • PCR

  • Others

  • Coagulation

  • Pharmaceuticals

  • Biologics

  • Vaccines

  • Blood

  • Tissues

  • Others

  • Microbiology

  • Pathogen Testing

  • Sterility Testing

  • Endotoxin & Pyrogen Testing

  • Growth Promotion Testing

  • Other Microbial Testing

  • Others

• Technology Outlook (Revenue, USD Million, 2016 - 2027)

  • Cell Culture

  • Spectrometry

  • Polymerase Chain Reaction

  • Chromatography

  • Immunoassays

  • Others

• End-use Outlook (Revenue, USD Million, 2016 - 2027)

  • Hospitals

  • Contract Research Organizations

  • Pharmaceutical & Biotechnology Companies

  • Academic Research

  • Diagnostic Laboratories

    • Independent Laboratories

    • Specialty Laboratories

• Regional Outlook (Revenue, USD Million, 2016 - 2027)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Singapore

    • Malaysia

    • Thailand

    • Vietnam

    • Oceania

  • Latin America

    • Brazil

    • Argentina

  • Middle East & Africa

    • South Africa

    • North Africa

    • UAE

    • Saudi Arabia

    • Qatar

    • Bahrain